Copyright Dickinson FDA Webview at www.fdaweb.com. Republished with permission. 09/25/2024 [Analysis by Jim Dickinson] Physician-attorney Jeff Shuren is gone from CDRH but his hand-picked interim successor, deputy director Michelle Tarver, continues his cozy-with-industry corruption of FDA’s patient safety mission at the Center. A troubling part of their legacy is the broken lives of patients devastated […]
LASIK Complaint on Violative Ads Seeks Woodcock Action
Copyright Dickinson FDA Webview at www.fdaweb.com. Republished with permission. 03/31/2021 The leader of a Facebook group involving patients injured by LASIK eye correction procedures is urging FDA acting commissioner Janet Woodcock to crack down on false and misleading advertising by LASIK providers. Paula Cofer, who founded the 7,400-member LASIK Complications Facebook Group in 2014 to […]
Modern laser in situ keratomileusis outcomes – A review.
The LASIK industry has a long history of manipulating data and publishing junk science to protect the public perception of LASIK. In 2009, leading LASIK surgeons published a literature review titled LASIK world literature review: quality of life and patient satisfaction1 which concluded that “95.4% of patients were satisfied with their outcome after LASIK surgery“. […]
FDA Lifts, Then Dashes LASIK Patients’ Hopes
Copyright Dickinson FDA Webview at www.fdaweb.com. Republished with permission. After a decade of stonewalling injured patients’ complaints about adverse reactions to LASIK vision-therapy laser surgeries, CDRH last week lifted their hopes for a change of heart at a one-hour meeting — then dashed them five days later in a 9/18 statement that doubled down on […]
Violative Medical Device Ads: Why FDA Doesn’t Act
Copyright Dickinson FDA Webview at www.fdaweb.com. Republished by permission. 01/04/2017 (Report by Jim Dickinson) FDA has statutory authority to regulate the advertising and promotion of “restricted” medical devices, but even in the face of injured patient complaints, it’s an authority it rarely uses. That’s probably because in the broad sweep of device safety issues and […]
Shuren Promises Action on Suicidal LASIK Patient
Copyright Dickinson FDA Webview at www.fdaweb.com. Republished by permission. 6/10/2016 Although CDRH has repeatedly refused in the face of mounting adverse reaction/injury reports to remove the LASIK indication from lasers labeled for that vision-enhancement indication, Center director Jeffrey Shuren 6/10 took less than 40 minutes to tell a LASIK activist CDRH would “look into” a […]
Hundreds Petition Congress to Fire CDRH’s Shuren
04-14-2016 Copyright Dickinson FDA Webview at www.fdaweb.com. Republished by permission. An Internet petition to Congress authored by LASIK injured patient/activist and former CDRH advisory committee consumer representative Paula Cofer has drawn more than 270 signatures from across the country in its first 24 hours, demanding the removal of CDRH director Jeffrey Shuren from office. Last […]
Despite Protests, FDA Hangs Tough on LASIK
9/9/2015 Copyright Dickinson FDA Webview at www.fdaweb.com. Republished by permission. Despite continued agitation on the part of patient activists claiming injuries from LASIK vision correction procedures, FDA said 9/9 it has “not found any new safety concerns associated with LASIK devices to lead it to believe that there is no longer a reasonable assurance that […]
1,073 LASIK Victims Ask FDA to Reconsider Petition Denial
Copyright Dickinson FDA Webview at www.fdaweb.com. Republished by permission. 05-08-2015 Attaching 1,073 signatures mostly from other purported victims of LASIK eye surgery, activist Paula Cofer 5/8 asked FDA acting commissioner Stephen Ostroff to reopen for consideration a petition from former CDRH ophthalmic device branch chief Morris Waxler that was denied last summer. The petition sought […]
Device Maker Slammed by Injured Patients at FDA Meeting
Copyright Dickinson FDA Webview at www.fdaweb.com. Republished by permission. 2/24/2015 Avedro Inc. CEO David Muller was verbally battered by several injured LASIK patients during public presentations 2/24 at a joint meeting of two FDA advisory committees as he led his company’s efforts to win an approval recommendation for a new drug/device combination to treat eye disorders […]